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Your Tax Dollars Are Being Wasted by Medicare

The title of this post may sound a little Tea Partyish, but stick with me here...

Medicare is projected to go broke by 2024. We need to do something about it. Here are a couple of news articles this week that identify some low hanging fruit.

1. Rita Redberg, UCSF cardiologist and editor of the respected Archives of Internal Medicine, had a terrific op-ed piece in the New York Times this week about overtreatment of older adults, paid for by Medicare. Some highlights (or lowlights)

40% of colonoscopies are administered to people over age 75 (screening guidelines suggest not screening after 75, and certainly not screening after age 85). Paid for by Medicare.

Kyphoplasty and Vertebroplasty, shown in two terrific randomized trials to be no better than sham procedures, are still funded by Medicare, to a tune of $1 BILLION/year.

Cardiac stents are no more effective than medication management or lifestyle changes in preventing heart attacks or death. Medicare cost: $1.4 BILLION/year.

1/5th of implantable cardiac defibrillators were placed without meeting guidelines for placement. Cost: $50,000 to $100,000 per device!

My favorite quote from Dr. Redberg:

Another factor is the shocking chasm between Medicare coverage and clinical evidence. Our medical culture is such that if the choice is between doing a test and not doing one, it is considered better care to do the test.

2. Pro-publica has been doing some terrific reporting recently. I previously posted on their terrific expose of the Heart Rhythm Society's shameless and absurdly lucrative relationship with the makers of implantable cardiac defibrillators (usually paid for by Medicare, as above). This week Pro-publica exposed a frankly disgusting relationship between the Society of Hospital Medicine and the drug company Sanofi-Aventis.

Here's the brief story:

Lovenox is a blood thinner commonly used in hospitalized patients to treat blood clots. It's made by Sanofi.

Sanofi has an interest in keeping cheaper generic versions of Lovenox off the market.

Sanofi paid the Society of Hospital Medicine more than 2.3 million between 2007 and 2010

Sanofi asked the Society of Hospital Medicine to write a letter to the FDA

The CEO of the Society of Hospital Medicine said in an email that although the society had never written a letter like that to the FDA..."That being said when something is important to any of our partners (like Sanofi) that we have a long term relationship with we want to give any issue that is important to our partner careful consideration."

The Society of Hospital Medicine wrote the (unprecedented) letter to the FDA, and another letter to the Wall Street Journal, cautioning against introduction of generic lovenox.

This "pay for delay" profits the drug companies at the expense of taxpayers and patients. It's yet another example of how drug and device money given to professional societies is tainted.

It's sick, really. The Society of Hospital Medicine should issue an apology, and return the money from Sanofi.

And transparency is not enough. Professional societies should not be allowed to take money from drug and device manufacturers. Period. It leads to too much abuse, erosion of public trust, and overtreatment that harms patients, particularly older adults. And industry profits often come at the expense of Medicare, paid for by you.

Your tax dollars, going to waste. Tea party, anyone?

by: Alex Smith

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Many drug companies have lost their way. Prandin is another drug that should have had a generic version 2 years ago. But no, my husband still pays over $600 every time he gets it filled. He needed a med for DM2 that is not sulfa based. It's not a Medicare fiasco, it's an ethical one.

The Society of Hospital Medicine (SHM) actions in the Lovenox affair are distressing and stunning.

This is not just an internal matter for SHM. When major medical organizations engage in such conduct, it scars the reputation of the entire medical profession.

The facts of this situation gets more distressing as more details emerge. The conclusion that SHM was coopted to act on behalf of an "industry partner" that supported SHM to the tune of millions seems inescapable.

In keeping with the title of Alex's post, how will we ever bring costs under control if our major professional organizations base their medical positions in the interests of their corporate sponsors instead of grounding these positions entirely in the interests of their patients?

The response of SHM has been equally distressing. It appears the public response to date has been to run a banner on its website noting, "SHM is committed to a culture of transparency with its industry partners."

What on earth does this mean? Are they trying to say that the next time they act on behalf of an "industry partner" they will disclose that their positions are based on helping corporate partners maximize their profits?

To date, it does not appear that SHM has grasped the seriousness of this episode. The character of the organization is at stake.

Is this a respectable and honorable organization that made a serious mistake that is prepared to learn from this mistake? Or regrettably, will we no longer be able to view SHM as a great organization that that reflects honorably on the medical profession.

I truly hope it is the former. But to believe this, SHM needs to deliver an unambiguous apology and clear statement that its actions in the Lovenox affair were inappropriate. This needs to be coupled with clear and specific actions that will be taken to assure that such an episode never recurs.

Great job, Alex, especially for pointing out the all too cozy relationship between big medical societies and drug companies. It will take a brave legislator and/or president to take these issues head on. Obama's appointment of Don Berwick to head CMS was a hopeful sign that we could head in the right direction, but we have a long way to go. Perhaps we need to do a better job of educating our patients (John Q. Public) that more is not better and that expectations for what constitutes good health care has got to change, big time. We clinicians have to stand up and do what is right, based upon sound evidence, and, at the same time, EXPLAIN what is right to our patients. The more we do this, the closer we get to changing the paradigm, and to keeping our health care system solvent.

Thanks Alex and Ken for raising this topic. I certainly tend to agree with your concerns and dismay.However, it may just be the contrarian in me, but there are a couple of points on which I would like to get your views before I rush any further to judgment.

1. Looking at the senate committee documents under the Pro-publica story, it looks like the Sanofi payments to SHM stretch over time and include the usual gamut of CME sponsorship, ads, and unrestricted gifts. To cite the figure of $2+ million makes it sound like a clearer quid pro quo than what it really is - a long-term relationship of SHM financial dependence upon Sanofi. Did anyone really think that Sanofi gave SHM money for no reason?

2. The Sanofi documents are very hard to read, but the parts not cited seem to suggest that Sanofi had concerns about the equivalence of generic alternatives to Lovenox because it is at least in part a biological and that FDA's processes for testing equivalence of biologicals might not be good enough. Now, I'm sure that is what someone trying to keep a competing product off the market would say, regardless, but I don't know how to evaluate that claim.

3. Lastly, I can't help putting myself in their shoes. The Foundation has given AGS and SHM (etc.) lots of money (more than $2M). We have positions on regulatory issues (non-profits are allowed to have opinions of regulatory issues - it's not lobbying in the eyes of the IRS). If AGS or SHM or anyone else were to agree with our positions, would it be sinister? Would it be sinister if we asked them to agree with our positions? In point of fact, when the IOM Retooling report was issued, we sent it around to all of our organizational grantees and asked them for endorsements. Was this wrong?

"Did anyone really think that Sanofi gave SHM money for no reason" - yes. At least that is the line that is given to members of medical societies. The promise is transparency and a strict code to carefully channel Pharma grants into specific activities where they will not have undue influence. The lesson here is not that SHM is a rogue operation with no moral compass. The lesson is that even respected societies can be easily influenced by companies bearing gifts.

Thanks for your comments Chris. I will respond to one of your points here, and to point 3 in another comment.

I agree that the $$ SHM received from Sanofi-Aventis were given over time, and that there is not a quid pro quo between the $$ and the lovenox FDA intervention in the very strictest sense.

On the other hand, it seems quite apparent that the support the company provided SHM created a desire to please their "partner." The SHM emails make this clear.

And this is exactly the outcome everyone fears when professional organizations accept industry support. There is often an assurance that the support comes with no conditions, and the professional societies assure their members and the public that it will not influence their recommendations.

But does anyone believe that SHM would have sent that letter to the FDA if they had not received support from Sanofi-Aventis?

As Eric points out, this illustrates that even credible respected organizations like SHM can be influenced with corporate $.

While this event is bad, SHM can recover from this. But they need to acknowledge they made a serious error (not just in failing to disclose their relationship to the FDA, but in submitting the FDA letter). Apology, acknowledgement, and a concrete committment not to repeat an error is what distinguishes a respected organization that has made a mistake from an organization that has lost its compass.

Your point about the potential for conflict of interest in relationships with nonprofits is fascinating. This is an issue that has not received enough discussion, and you doing an important service by raising the issue.

I think many would argue that there are less conflict concerns when the organization supplying the $$ does not stand to gain financially from the actions of the $$ recipient. I think a strong sense could be made that this markedly lessens the chances of inappropriate influence. It is also true that in the case of foundation grants there is usually a very strong commonality of missions between the grantee and recipient. This further lessens the chance of inappropriate influence.

But it also seems unreasonable to argue that there is no potential for conflict of interest or inappropriate influence.

As a hypothetical, consider the case of IMPACT, a Hartford funded intervention that improved the care of geriatric depression. What if the intervention had been shown to be unsuccessful? Would the board of trustees have been less happy? Probably. Yet, if the study had been unsuccessful, the authors would have had the same societal obligation to publish their findings, aiming for the widest possible dissemination.

So, when a foundation supports research or interventions, it does seem that there need to be clear steps taken to make sure that dissemination occurs, regardless of the results. I may have faith that this would have actually occurred, but avoidance of conflicts is not based on faith---but a recognition that even the best people are influenced by financial support, and steps need to be taken to avoid this.

The endorsement of the IOM report is a very interesting issue--and would love to hear what others think. It is hard to believe that your grantees were not enthusiastic about the recommendations.

Yet, I do think as a funder of those organizations, it is a mistake to ask them for an endorsement. When it comes to policy recommendations, it is important that the public believe that professional organizations are making their own independent determination, and speaking on behalf of their mission. When an important funder asks you to endorse a policy statement, it becomes difficult to believe that they have made an independent determination.

Perhaps one of the central mistakes made by those concerned about conflict of interest is the suggestion that conflict policies are necessary because "bad people", "bad companies", or "bad organizations" can be influenced by money.

It is really quite the opposite. They are needed because the very best people, companies, and organizations can be influenced by money. Everyone is susceptible to this influence.

From this perspective, it is important that we not assume we are immune from conflict or influence because our mission is grounded in a public good.

Thank you, Alex and all, for provocative and ever-timely comments about PhRMA and the medical profession. I would only point out what Ken briefly alludes to - and what Arnold Relman and Marcia Angell have written about for years - that payments for CME and to individual physicians for research (real and imagined research) are as problematic as payments to medical societies. And, "transparency" or "disclosure" are insufficient answers to the problem. Just say 'no' is the answer. As Ken says, we are all susceptible to conflict of interest. It can be very subtle; we can deceive ourselves and others into thinking it ain't so. Well, it ain't so that it ain't so; just say no.

Thanks to everyone for all the comments and tweets. I just want to forward the response of the Society of Hospital Medicine's CEO, Larry Wellikson (thanks for forwarding Sei!). Basically he says sorry, my bad, we're more transparent now. Stronger action is needed (I'll resist the Jim Tressel comparison - although it's hard). Here's what Wellikson says:

In recent days SHM has been in the media concerning our relationships with sanofi-aventis and a letter I wrote to the FDA. I want to speak directly to the SHM membership about this issue.

For several years SHM has worked on projects to prevent venous thromboembolism with funding support from sanofi-aventis. During the course of that relationship, representatives from sanofi-aventis approached SHM about the issue of bioavailability of generic low-molecular-weight heparins, and asked if SHM would consider writing a letter to the FDA asking that consideration be given to requiring additional clinical trial evidence on the efficacy of of generic low-molecular-weight heparins prior to approving these medications. While SHM does not routinely send letters to the FDA, it often makes comments and writes letters to many other government organizations and individuals, including CMS and members of Congress.

In doing our due diligence on gathering the scientific facts on this matter, I met with academic experts on the subject and reviewed the scientific literature. I decided there was enough scientific basis to write a letter on behalf of SHM to the FDA indicating that, while SHM generally supports the use of generic drugs, it might make sense in the class of low-molecular-weight heparins to perform additional testing to assure that generic substitutes would provide full pharmaceutical effect for our patients during their treatment.

Though SHM had an ongoing relationship with sanofi-aventis in which they were funding SHM quality improvement projects, I neglected to disclose this relationship in my letter to the FDA. SHM did publicly disclose its relationships with industry on our web site and in other public reports, but looking back now I clearly see how the FDA would have been better served to have had the full details of this relationship presented in our letter along with our scientific comments, so that they could have considered my comments letter in this context. I regret that omission and its impact on SHM’s reputation for being straightforward and transparent.

I cannot rewind the past. What I can do, and what we have done in the past year, is commit to implementing the strong policies for disclosure and transparency that the SHM Board put in place in 2010, which are available at www.hospitalmedicine.org/industry.

As explained in SHM Past President Jeff Wiese’s October 2010 article in The Hospitalist titled, To Err is Human, these policies outline that SHM will not comment on any drug or device unless the communication is first fully reviewed and approved by its Board of Directors. Further, all communications from SHM now contain a standard footer on the Society's printed and electronic letterhead that directs the recipient to an SHM conflicts of interest webpage, which outlines all of SHM’s relationship with industry.

I sincerely regret that my actions in this instance have drawn attention away from the exceptional work that hospitalists are doing every day and the work that SHM continues to do to support those efforts. I regret any negative impact this situation has had on the Society of Hospital Medicine.

I welcome your input and questions on this important issue and ongoing dialogue. Please feel free to contact me at lwellikson@hospitalmedicine.org.

I am committed to providing the future leadership that you, SHM and our specialty deserve and that you have come to expect from me.

It was gratifying to see emphasis on clinical evidence in the portion of this post that deals with ongoing Medicare expenditure for procedures for which evidence of medical efficacy is sorely lacking. These do, indeed, represent low-hanging fruit that begs to be picked. More to the point, we have clinical evidence to drive our decision-making here.

A discussion of evidence was, however, visibly lacking in the presentation of the financial relationship between SHM and Sanofi. I could find the conspiracy theory more acceptable if I knew, for example, that generic enoxaparin is therapeutically equivalent to brand-name Lovenox (r). Conversely, if there is evidence that generic enoxaparin is significantly inferior to brand-name Lovenox (r), it is difficult to argue that SHM's position is anything other than supported by evidence.

Now that we are in the world of direct-to-consumer advertising of all sorts of drugs and biologicals, it is difficult to presume that anyone is free from commercial influence.

Even banning all industry support from professional society meetings will not rid the individual physician of the responsibility of looking at published output with a critical eye.

It was gratifying to see emphasis on clinical evidence in the portion of this post that deals with ongoing Medicare expenditure for procedures for which evidence of medical efficacy is sorely lacking. These do, indeed, represent low-hanging fruit that begs to be picked. More to the point, we have clinical evidence to drive our decision-making here.

A discussion of evidence was, however, visibly lacking in the presentation of the financial relationship between SHM and Sanofi. I could find the conspiracy theory more acceptable if I knew, for example, that generic enoxaparin is therapeutically equivalent to brand-name Lovenox (r). Conversely, if there is evidence that generic enoxaparin is significantly inferior to brand-name Lovenox (r), it is difficult to argue that SHM's position is anything other than supported by evidence.

Now that we are in the world of direct-to-consumer advertising of all sorts of drugs and biologicals, it is difficult to presume that anyone is free from commercial influence.

Even banning all industry support from professional society meetings will not rid the individual physician of the responsibility of looking at published output with a critical eye.

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